A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1- Antihistamines

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

ClinicalTrials.gov Identifier: NCT05032157

Novartis Reference Number: CLOU064A2302

Last Update: Feb 03, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

Condition 
Chronic Spontaneous Urticaria
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Dec 01, 2021
Completion date 
Mar 01, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LOU064 (blinded)
LOU064 (blinded) active treatment
Drug
Placebo
Placebo
Drug
LOU064 (open-label)
LOU064 (open -label) active treatment

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Male and female adult participants ≥18 years of age at the time of screening.
CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation).
Diagnosis of CSU inadequately controlled by second generation H1-antihistamines at the time of randomization defined as:
The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of second generation H1-antihistamines during this time period
UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0-21) ≥ 6 during the 7 days prior to randomization (Day 1)
Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants medical history).
Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.
Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1).

Exclusion Criteria:

Participants having a clearly defined predominant or sole trigger of their chronic urticaria (CU) (chronic inducible urticaria (CINDU)) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria
Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria
Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis
Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York heart association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant
Significant bleeding risk or coagulation disorders
History of gastrointestinal bleeding, e.g. in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g. requiring hospitalization or blood transfusion)
Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel. The use of dual anti-platelet therapy (e.g. acetylsalicylic acid + clopidogrel) is prohibited.
Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC))
History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening

Study Locations

United States
Novartis Investigative Site
Recruiting
Litchfield Park, 85340
Arizona
United States
Novartis Investigative Site
Recruiting
Little Rock, 72205
Arkansas
United States
Novartis Investigative Site
Recruiting
San Diego, 92123
California
United States
Novartis Investigative Site
Recruiting
Clearwater, 33756
Florida
United States
Novartis Investigative Site
Recruiting
Pembroke Pines, 33028
Florida
United States
Novartis Investigative Site
Recruiting
Savannah, 31406
Georgia
United States
Novartis Investigative Site
Recruiting
Boise, 83706
Idaho
United States
Novartis Investigative Site
Recruiting
Louisville, 40215
Kentucky
United States
Novartis Investigative Site
Recruiting
Owensboro, 42301
Kentucky
United States
Novartis Investigative Site
Recruiting
Baltimore, 21204
Maryland
United States
Novartis Investigative Site
Recruiting
Waldorf, 20602
Maryland
United States
Novartis Investigative Site
Recruiting
White Marsh, 21162
Maryland
United States
Novartis Investigative Site
Recruiting
Troy, 48084
Michigan
United States
Novartis Investigative Site
Recruiting
Warrensburg, 64093
Missouri
United States
Novartis Investigative Site
Recruiting
Missoula, 59808
Montana
United States
Novartis Investigative Site
Recruiting
Skillman, 08558
New Jersey
United States
Novartis Investigative Site
Recruiting
Grove City, 43123
Ohio
United States
Novartis Investigative Site
Recruiting
Oklahoma City, 73120
Oklahoma
United States
Novartis Investigative Site
Recruiting
Pittsburgh, 15241
Pennsylvania
United States
Novartis Investigative Site
Recruiting
North Charleston, 29420
South Carolina
United States
Novartis Investigative Site
Recruiting
Murfreesboro, 37130
Tennessee
United States
Novartis Investigative Site
Recruiting
Leander, 78641
Texas
United States
Novartis Investigative Site
Recruiting
Salt Lake City, 84102
Utah
United States
Novartis Investigative Site
Recruiting
Greenfield, 53228
Wisconsin
United States
Canada
Novartis Investigative Site
Recruiting
Kingston, K7L 2V7
Ontario
Canada
Novartis Investigative Site
Recruiting
London, N6H 5L5
Ontario
Canada
Novartis Investigative Site
Recruiting
Niagara Falls, L2H 1H5
Ontario
Canada
Novartis Investigative Site
Recruiting
Toronto, M3B 3S6
Ontario
Canada
Novartis Investigative Site
Recruiting
Verdun, H4G 3E7
Quebec
Canada
China
Novartis Investigative Site
Recruiting
Chengdu, 610041
Sichuan
China
Germany
Novartis Investigative Site
Recruiting
Bad Bentheim, 48455
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22391
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Poland
Novartis Investigative Site
Recruiting
Lodz, 90-265
-
Poland
Novartis Investigative Site
Recruiting
Poznan, 60-693
-
Poland
Novartis Investigative Site
Recruiting
Poznan, 60-823
-
Poland
Novartis Investigative Site
Recruiting
Warszawa, 02-507
-
Poland
Russian Federation
Novartis Investigative Site
Recruiting
Ryazan, 390039
-
Russian Federation
Novartis Investigative Site
Recruiting
Ryazan, 390046
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 196158
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 199226
-
Russian Federation
Novartis Investigative Site
Recruiting
Stavropol, 355000
-
Russian Federation
Slovakia
Novartis Investigative Site
Recruiting
Svidnik, 08901
-
Slovakia
Novartis Investigative Site
Recruiting
Topolcany, 95501
-
Slovakia
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3010
-
Switzerland
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40705
-
Taiwan
Novartis Investigative Site
Recruiting
Taoyuan, 33305
-
Taiwan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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Call 1-888-669-6682 or email [email protected]